Spiritual Care or Psychotherapy Versus Palliative Care Alone in Patients With Non-Curative Malignancies (SPC)

The Methodist Hospital Research Institute (TMHRI)

Status and phase: Enrolling; Phase 3

Conditions: Cancer

Treatments: Behavioral: Chaplain-Provided Spiritual Care; Behavioral: Psychotherapy and Meditation Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07290491

PRO00037917 (HMCC-BR23-001)

Details and patient eligibility

About

This phase III clinical trial will evaluate the impact on survival of adding chaplain-provided spiritual care or psychotherapy/meditation to standard-of-care (SOC) and palliative measures, plus chemotherapy if recommended, and comparing it with SOC and palliative measures, plus chemotherapy if recommended, in patients with non-curative malignancies. The Palliative Care Department at Houston Methodist Hospital provides essential services to patients diagnosed with advanced cancer by sharing information and resources about symptom management, pain treatment and planning for the future. It is also recognized that chaplaincy-based spiritual care of patients can be a valuable part of interdisciplinary interventions in oncology.

Enrollment: 854 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients are eligible to be included in the trial only if all of the following criteria apply

• The patient provides written informed consent for the trial.
• Male or female ≥18 years of age on the day of informed consent signing.
• Histologically confirmed metastatic disease with life expectancy of one year or less.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
• Willing and able to comply with the protocol for the duration of the trial including undergoing scheduled visits and interventions.

Exclusion criteria

Patients are excluded from the trial if any of the following criteria apply:

• Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. If a patient develops a psychiatric disorder after baseline, he/she will not be taken off the trial.
• Mobility limitations that would interfere with cooperation with the requirements of the trial.
• Confirmed positive pregnancy test in women of child bearing potential.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

854 participants in 2 patient groups

Spiritual Care or Psychotherapy/Meditation with SoC and Palliative Measures, plus Chemotherapy

Experimental group

Description:

Patients will receive either individual spiritual care from a Houston Methodist Hospital chaplain or personal psychotherapy/meditation from a psychotherapist/ meditation instructor in addition to Standard of Care and Palliative Measures, plus Chemotherapy if recommended for 24 sessions (one hour per session) over 24 weeks, per patients' choice.

Treatment:

Behavioral: Psychotherapy and Meditation Intervention

Behavioral: Chaplain-Provided Spiritual Care

Standard of Care and Palliative Measures, plus Chemotherapy

No Intervention group

Description:

Patients will receive Standard of Care and palliative measures, plus chemotherapy if recommended over 24 weeks.